Here are some of the latest health and medical news developments, compiled by the editors of HealthDay:
Parkinson’s Drug May Increase Risk of Cardiovascular Events: FDA
Study data suggest that Parkinson’s disease patients taking the drug Stalevo (a combination of carbidopa/levodopa and entacapone) may be at greater risk for heart attack, stroke and cardiovascular death than patients taking the drug Sinemet (carbidopa/levodopa), the U.S. Food and Drug Administration said Friday.
The FDA is evaluating the data from the STRIDE-PD trial and recommends that doctors regularly evaluate the cardiovascular health of patients taking Stalevo, especially if they have a history of cardiovascular disease.
Patients should not stop taking Stalevo unless told to do so by their doctor, the FDA said in a news release.
The agency said it’s looking at additional ways to assess whether Stalevo increases the risk of cardiovascular events and will update the public once it completes its review.
Stalevo was approved by the FDA in June 2003 and about 154,000 patients had received a prescription for the drug through October 2009.
—–
FDA Panel Endorses Antidepressant for Back Pain
The antidepressant Cymbalta should be approved to treat lower back pain, a U.S. Food and Drug Administration advisory panel recommended Thursday.
However, the panel voted against the use of the drug to treat osteoarthritis, The New York Times reported. Cymbalta is made by Eli Lilly.
While the FDA doesn’t have to, it usually follows the recommendations of its advisory panels.
After the vote, the advisory panel chair criticized Lilly for a Cymbalta advertising campaign that says “depression is painful.” The ads appeared to be an attempt to “premarket” Cymbalta for a pain use that has not yet been approved by the FDA, said Dr. Jeffrey R. Kirsch, chairman of the department of anesthesiology at the Oregon Health Sciences University, the Times reported.
Currently, Cymbalta has FDA approval for treatment of major depression, nerve pain, generalized anxiety disorder, and fibromyalgia, the newspaper said.
—–
Baseball Pitcher Roger Clemens Denies Steroid Use
Pitching legend Roger Clemens continued Thursday to deny that he used performance-enhancing drugs, after a federal grand jury indicted him for allegedly lying to Congress about his use of human growth hormone and steroids.
“I never took HGH or steroids. And I did not lie to Congress,” Clemens said on Twitter, the Associated Press reported. “I look forward to challenging the government’s accusations, and hope people will keep an open mind until trial. I appreciate all the support I have been getting. I am happy to finally have my day in court.”
Clemens faces a six-count indictment alleging that he obstructed a congressional inquiry with 15 different statements made under oath, including saying that he never used human growth hormone or steroids.
The seven-time Cy Young winner is the latest baseball superstar to become embroiled in the steroid scandal that has tainted the sport. Slugger Mark McGwire has admitted to using steroids and all-time home run leader Barry Bonds is scheduled to go on trial in March. Bonds faces charges of lying to a federal grand jury for stating that he never knowingly used performance-enhancing drugs, the AP reported.
—–
Drug Company Letter About Avandia Misleading: U.S.
A GlaxoSmithKline letter sent to doctors presents misleading information about a trial involving the diabetes drug Avandia and could endanger patients, U.S. drug regulators say.
In a July hearing, a U.S. Food and Drug Administration expert advisory panel discussed the heart risks of Avandia and the ethics of an ongoing trial comparing Avandia to a similar drug called Actos, made by Takeda Pharmaceuticals, The New York Times reported.
The FDA has ordered GlaxoSmithKline to stop recruiting new patients for the Tide trial but current patients can continue in the study. At the hearing, Dr. David Graham, an FDA medical officer, argued that the trial should be stopped because thousands of participants were being exploited, the newspaper said.
Federal officials ordered GlaxoSmithKline to send a letter describing the hearing to doctors involved in the Tide trial. But the letter doesn’t mention any of Graham’s statements about patient welfare, the Times said.
“This summary is biased, misleading and not truthful,” Graham told the Times. “The whole purpose of this letter is so that they can reassess whether this is an ethical trial going forward, but the step-by-step ethical flaws and problems with the Tide trial are not even referenced.”
Several members of the FDA advisory committee also said the GlaxoSmithKline letter was biased, the newspaper said.